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What is Zelthy Regulatory Affairs?

Zelthy Regulatory Affairs is an innovative software solution tailored for teams in the pharmaceutical and biotechnology industries, streamlining the management of submissions to multiple health authorities and regulatory bodies. It provides a detailed overview of submission pipelines, essential milestones, jurisdiction-specific requirements, and health authority inquiries. The platform enables teams to systematically arrange regulatory dossiers, validate publishing packages, coordinate the review process, and oversee post-approval variations and labeling changes. In addition, regulatory intelligence features are included to track updates in guidelines and requirements, assess their impact on portfolios, and uncover any gaps in dossier preparedness. Enhanced by AI capabilities, it assists in the creation of documents and the drafting of materials needed for regulatory evaluations. Moreover, Zelthy integrates seamlessly with enterprise systems like Veeva RIM and offers deployment options that include cloud, on-premises, or hybrid solutions, ensuring adaptability to meet diverse organizational needs. This all-encompassing approach not only enhances efficiency but also supports regulatory teams in maintaining compliance, making Zelthy an indispensable tool in their operational arsenal. With a focus on continuous improvement and innovation, Zelthy empowers organizations to navigate the complex regulatory landscape effectively.

What is PhlexRIM?

PhlexRIM promises to greatly improve compliance by offering instantaneous access to worldwide registration data in a remarkably efficient way. The newest iteration, PhlexRIM 2.0, introduces a suite of pre-configured automation assistants, referred to as "bots," along with regulatory scenarios that comply with industry standards. Its user-friendly drag-and-drop design interface empowers regulatory teams to optimize their workflows without the necessity for programming knowledge or IT support. Moreover, it efficiently manages the lifecycle of pharmaceutical product registration, allowing users to obtain comprehensive status updates and utilize the alert management system embedded in all processes. The reporting functions are extensive, providing options for both standard reports and the ability to craft custom reports that meet specific requirements. Furthermore, the platform supports the development and delegation of regulatory tasks across multiple organizational levels, including management, departments, headquarters, and affiliates, fostering effective teamwork and collaboration among diverse teams. This comprehensive functionality positions PhlexRIM 2.0 as a crucial tool for regulatory compliance and operational efficiency in the pharmaceutical sector.

Media

Media

Integrations Supported

Adobe Acrobat Sign
Amazon Web Services (AWS)
Docusign
Google Workspace
Microsoft 365
Microsoft Azure
NiCE CXone Mpower
Salesforce
Snowflake
TraceLink
Twilio
Veeva CRM
Veeva Vault
Veeva Vault RIM
Zelthy Platform

Integrations Supported

API Availability

Has API

API Availability

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided

Supported Platforms

SaaS
On-Prem

Supported Platforms

SaaS

Customer Service / Support

Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Not specified

Training Options

Documentation Hub
Webinars
Online Training

Company Facts

Organization Name

Healthlane Technologies

Date Founded

2017

Company Location

India

Company Website

www.zelthy.com/solutions/regulatory

Company Facts

Organization Name

Phlexglobal

Date Founded

1997

Company Location

United Kingdom

Company Website

www.phlexglobal.com/phlexrim

Categories and Features

Categories and Features

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